Chronic drug shortages that threaten patient care are caused by rock-bottom prices for older generic medicines and a health care marketplace that doesn’t run on the rules of supply and demand, among other factors, according to a federal report published Tuesday.
The report, the work of a task force led by the Food and Drug Administration and comprising representatives from various federal agencies, recommended that buyers like hospitals consider paying higher prices for older generic drugs.
Paying more would encourage drug companies to prioritize drugs like vincristine, a critical cancer medicine for children that now sells for just $8 a vial. To the consternation of cancer specialists, supplies of the drug recently have been scarce.
Cancer drugs are not the only medications in short supply. At any given time in the United States, there are shortages of well over 100 drugs, including many used for anesthesia, palliative care and septic shock, as well as vaccines and medical supplies like sterile water.
The number of such shortages has been growing, according to the report. The shortages also are lasting longer, in some cases for years.
An analysis in the report found that two-thirds of 163 drugs in short supply in recent years were available as generics, generally at low cost. The medications were older, too, on the market for a median of almost 35 years.
But quality-control problems at manufacturing facilities were responsible for more than half of recent drug shortages, the task force also found.
The group’s proposed solutions also included new “quality ratings” that might help drug companies attract higher prices and increase market share. (Many shortages, however, occur when problems affect a company that is the sole supplier of a drug.)
The task force stopped short of suggesting greater governmental involvement in drug procurement, concluding that the shortages are likely to continue absent dramatic changes in the “broken marketplace.”
That was a disappointment to doctors on the front lines of care, especially those treating children with cancer.
“The government has previously stepped into the marketplace to assist the ailing automotive industry, Wall Street and the insurance companies,” said Dr. Yoram Unguru, who treats children with cancer at the Herman and Walter Samuelson Children’s Hospital at Sinai in Baltimore. “Why not do the same for our ailing health care system, specifically the manner in which lifesaving medications are manufactured and distributed?”
Essential medications should be viewed as “critical infrastructure, not unlike public utilities such as electricity and water,” Unguru added. Preventable cancer drug shortages “are unacceptable and ethically unjustifiable,” he said.
A shortage of a generic cancer drug, vincristine, has panicked parents in recent weeks and sent doctors scrambling to secure supplies. Vincristine is the backbone of treatment for many childhood cancers and is critical in the treatment of acute lymphoblastic leukemia, the most common childhood cancer.
But the solutions proposed in the federal report, if put in place, may not have any effect in the near term, said Dr. Peter C. Adamson, chairman of the Children’s Oncology Group, an international body, and “fall short in ensuring that today’s children with cancer will not continue to be placed at risk.”
A spokeswoman for Pfizer, the sole supplier of vincristine in the United States, said that the company believed deliveries would meet patient needs through the end of the year, and that the company expected to fully recover from the shortage by January.
“In terms of filling orders, it depends on the date of the order, the level of customer inventory and the exact customer need,” the spokeswoman said. “We are doing all we can to make sure no patient misses a single dose.”